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Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study.
Nephrology (Carlton). 2017 Apr; 22(4):293-300.N

Abstract

AIM

We aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia.

METHODS

In this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non-inferiority of PA21 was confirmed if the upper limit of the two-sided 95% confidence interval (CI) is ≤0.32 mmol/L. Secondary outcomes were corrected serum calcium and intact-parathyroid hormone concentrations. Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated.

RESULTS

The adjusted mean serum phosphorus concentration at the end of treatment confirmed the non-inferiority of PA21 for lowering serum phosphorus compared with sevelamer (1.62 vs 1.72 mmol/L; difference, -0.11 mmol/L; 95% CI, -0.20 to -0.02 mmol/L). The mean daily tablet intake was 5.6 ± 2.6 and 18.7 ± 7.1 tablets in the PA21 and sevelamer groups, respectively. The incidences of AEs and ADRs were not significantly different between the two groups.

CONCLUSION

The non-inferiority of PA21 to sevelamer was confirmed for the treatment of Japanese haemodialysis patients with hyperphosphataemia. PA21 was effective, safe, and well tolerated, while having a considerably lower pill burden than sevelamer.

Authors+Show Affiliations

Division of Nephrology, Department of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.Biostatistics, Faculty of Pharmaceutical Sciences, Josai University, Sakado, Japan.Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27496336

Citation

Koiwa, Fumihiko, et al. "Efficacy and Safety of Sucroferric Oxyhydroxide Compared With Sevelamer Hydrochloride in Japanese Haemodialysis Patients With Hyperphosphataemia: a Randomized, Open-label, Multicentre, 12-week Phase III Study." Nephrology (Carlton, Vic.), vol. 22, no. 4, 2017, pp. 293-300.
Koiwa F, Yokoyama K, Fukagawa M, et al. Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study. Nephrology (Carlton). 2017;22(4):293-300.
Koiwa, F., Yokoyama, K., Fukagawa, M., Terao, A., & Akizawa, T. (2017). Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study. Nephrology (Carlton, Vic.), 22(4), 293-300. https://doi.org/10.1111/nep.12891
Koiwa F, et al. Efficacy and Safety of Sucroferric Oxyhydroxide Compared With Sevelamer Hydrochloride in Japanese Haemodialysis Patients With Hyperphosphataemia: a Randomized, Open-label, Multicentre, 12-week Phase III Study. Nephrology (Carlton). 2017;22(4):293-300. PubMed PMID: 27496336.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III study. AU - Koiwa,Fumihiko, AU - Yokoyama,Keitaro, AU - Fukagawa,Masafumi, AU - Terao,Akira, AU - Akizawa,Tadao, PY - 2016/03/30/received PY - 2016/08/02/revised PY - 2016/08/03/accepted PY - 2016/8/9/pubmed PY - 2017/3/14/medline PY - 2016/8/7/entrez KW - PA21 compound KW - haemodialysis KW - hyperphosphataemia KW - sevelamer KW - sucroferric oxyhydroxide SP - 293 EP - 300 JF - Nephrology (Carlton, Vic.) JO - Nephrology (Carlton) VL - 22 IS - 4 N2 - AIM: We aimed to investigate the non-inferiority of PA21 (sucroferric oxyhydroxide) to sevelamer hydrochloride (sevelamer) in terms of efficacy and safety in Japanese haemodialysis patients with hyperphosphataemia. METHODS: In this Phase III, open-label, multicentre study, 213 haemodialysis patients with hyperphosphataemia were randomized to PA21 or sevelamer treatment for 12 weeks. The primary outcome was adjusted serum phosphorus concentration at the end of treatment; the non-inferiority of PA21 was confirmed if the upper limit of the two-sided 95% confidence interval (CI) is ≤0.32 mmol/L. Secondary outcomes were corrected serum calcium and intact-parathyroid hormone concentrations. Adverse events (AEs) and adverse drug reactions (ADRs) were evaluated. RESULTS: The adjusted mean serum phosphorus concentration at the end of treatment confirmed the non-inferiority of PA21 for lowering serum phosphorus compared with sevelamer (1.62 vs 1.72 mmol/L; difference, -0.11 mmol/L; 95% CI, -0.20 to -0.02 mmol/L). The mean daily tablet intake was 5.6 ± 2.6 and 18.7 ± 7.1 tablets in the PA21 and sevelamer groups, respectively. The incidences of AEs and ADRs were not significantly different between the two groups. CONCLUSION: The non-inferiority of PA21 to sevelamer was confirmed for the treatment of Japanese haemodialysis patients with hyperphosphataemia. PA21 was effective, safe, and well tolerated, while having a considerably lower pill burden than sevelamer. SN - 1440-1797 UR - https://www.unboundmedicine.com/medline/citation/27496336/Efficacy_and_safety_of_sucroferric_oxyhydroxide_compared_with_sevelamer_hydrochloride_in_Japanese_haemodialysis_patients_with_hyperphosphataemia:_A_randomized_open_label_multicentre_12_week_phase_III_study_ L2 - https://doi.org/10.1111/nep.12891 DB - PRIME DP - Unbound Medicine ER -